FDA Considers New Office of Patient Affairs

The Food and Drug Administration (FDA) is considering establishing a new Office of Patient Affairs to enhance future patient engagement by providing a more transparent and accessible experience for patient communities.

FDA recognizes the importance of engaging with patients, caregivers, and their advocates in the medical product development process under the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July 2012. The FDASIA expanded the FDA's authorities and strengthened its ability to safeguard and advance public health in several areas, including increasing stakeholder involvement in FDA regulatory processes.

The proposed new Office of Patient Affairs will be tasked with supporting and coordinating patient engagement activities across medical product centers and other offices that engage with patients and their advocates on matters pertaining to medical products. The responsibilities of this central office would include offering a single, central entry point to the FDA for the patient community and providing triage and navigation services for inbound inquiries from patient stakeholders. The office will also be responsible for hosting and maintaining data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and FDA's relationships with patient communities. It will also develop a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

As part of this effort, the FDA has identified the following two objectives: develop an understanding of the patient experience of disease and support patients and their advocates in understanding regulatory processes and navigating the FDA. To meet these goals, the FDA intends to:

gather patient perspective on what is clinically meaningful

assess attitudes towards benefit-risk and tolerance of uncertainty

enhance the science of eliciting and integrating patient input

communicate relevant FDA positions, procedures, and activities

connect patients and their advocates with the appropriate resources

resolve discrete challenges and needs.

Under this proposal, the Office of Patient Affairs would be directly accountable to the medical product centers. In addition, a regular evaluation of this central office and of FDA's overall patient engagement efforts is proposed, which will include feedback from external stakeholders, including patients and their advocates, on a biennial basis. This concept was directly informed by earlier public feedback solicited by the FDA regarding FDA's stakeholder engagement responsibilities outlined by the FDASIA.